1. Field of the Invention
The present invention is in the field of formulations of xcex2-carotene, and methods of using such formulations. More particularly, the present invention relates to clear micellized formulations of xcex2-carotene adapted for treating leukoplakia in human patients, and to the process of such treatment.
2. Brief Description of the Prior Art
xcex2-carotene is a well known naturally occurring substance and has been used in the prior art in nutritional supplements, vitamin or vitamin related formulations, as well as in other formulations applied to the human skin. U.S. Pat. No. 4,572,915 describes clear, micellized aqueous formulations of several fat soluble vitamins, essential nutrients, herb oils and other fat soluble pharmaceutical agents, including a formulation of xcex2-carotene. The formulations of U.S. Pat. No. 4,572,915 are to be ingested by humans as nutritional and/or vitamin supplements.
Leukoplakia is a disease characterized by formation of white or off-white colored lesions in the mouth which have the potential of developing into oral cancer. It follows that partial or total elimination of the pre-malignant leukoplakia lesions is medically desirable, and may well serve as a life-saving measure by preventing the development of potentially disfiguring or fatal oral cancer. The present invention provides a xcex2-carotene formulation which is specifically adapted for treating leukoplakia lesions with highly favorable results.
It is an object of the present invention to provide a clear, micellized aqueous formulation of xcex2-carotene in a gel or oral rinse form.
It is another object of the present invention to provide a method for treating leukoplakia in human patients.
The foregoing and other objects and advantages are attained by a formulation which contains water, xcex2-carotene, a water miscible polyol, an unsaturated fatty acid ester, and a surfactant which is preferably polyethoxylated castor oil, polysorbate or polyethoxyethylene stearate. The formulation preferably also contains a pharmaceutically acceptable anti-oxidant, preferably d-alpha-tocopherol (vitamin E) or its pharmaceutically acceptable derivatives having vitamin E activity. The formulation may be provided as an oral rinse or as a gel well suited for spreading on gums or other parts of the oral cavity.
The method of treatment in accordance with the invention comprises applying the formulation of the invention in the gel or oral rinse form on a substantially regular daily basis to areas in the oral cavity where leukoplakia lesions are present. Persistent application of the formulation results in substantial diminution or total elimination of the leukoplakia lesions.